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The monthly reporting of placing on the Romanian market, respectively of sales of medicinal products for human use by authorized wholesale distributors/importers/manufacturers*
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Procedure
Online
Companii
National
The purpose of this procedure is the submission by authorized manufacturers, importers, and wholesale distributors of monthly reports regarding all commercial operations, including parallel import, as well as the distribution of medicines outside the territory of Romania, to other states in the European Economic Area, carried out with human medicinal products from their own portfolio, according to the provisions of the Minister of Health Order no. 502/2013.
The final purpose of the reporting is to ensure the traceability of medicines throughout the entire chain, from manufacturing and/or distribution up to the level of community pharmacy, hospital pharmacy, and drugstore, to verify the correctness of releasing medicines with or without medical prescription, to detect falsified medicines and to prevent their entry into the authorized distribution network, to combat the existence of illegal parallel circuits for the sale of medicines, and to guarantee the rapid withdrawal of non-compliant batches of medicines or in cases of health emergencies.
The reporting is prepared in accordance with the Guide on completing the table for the monthly electronic reporting of medicines distributed by wholesale distributors/importers/manufacturers provided in the Annex to the Minister of Health Order no. 502/2013 and is submitted, together with the statement on own responsibility of the legal representative of the company performing the reporting regarding the compliance of the transmitted data, on the PCUe platform.
*The final purpose of the reporting is to ensure the traceability of medicines throughout the entire chain, from manufacturing and/or distribution up to the level of community pharmacy, hospital pharmacy, and drugstore, to verify the correctness of releasing medicines with or without medical prescription, to detect falsified medicines and to prevent their entry into the authorized distribution network, to combat the existence of illegal parallel circuits for the sale of medicines, and to guarantee the rapid withdrawal of non-compliant batches of medicines or in cases of health emergencies.
The reporting is prepared in accordance with the Guide on completing the table for the monthly electronic reporting of medicines distributed by wholesale distributors/importers/manufacturers provided in the Annex to the Minister of Health Order no. 502/2013 and is submitted, together with the statement on own responsibility of the legal representative of the company performing the reporting regarding the compliance of the transmitted data, on the PCUe platform.
Entitled persons
Regulated professions
Required documents
Denumire
Descriere
Obligatoriu
Semnătură digitală
Tip document
Descarcă
-
The situation (monthly report) regarding commercial operations*
Descarcă
Formular tipizat
It is to be prepared only in .xls format, in two separate tables, one for OTC medicines and the other for prescription-only medicines. Download the template, fill it in, and then upload it to the platform.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
The statement on own responsibility of the legal representative (includes the contact details of the person who completed each report)*
Descarcă
Scanned document
It is drawn up as an informative document, it is signed, stamped, scanned, and then uploaded to the platform.*
Document obligatoriu
Semnatură digitală obligatorie
Se poate obține prin OOTS
Issued documents
Denumire
Tip document
Descarcă
-
None
Fees
Title
Payment method
Value
Currency
None
Deadlines
Resolution time:
30
Calendar days
Case filling duration:
0
Calendar days
Notification deadline:
1
Calendar days
Legislation
Appeal routes
Any person who considers themselves harmed in a right or in a legitimate interest, by ANMDMR through an administrative act or by failure to resolve a request within the legal term, may address the competent administrative court under the conditions established by the Law on Administrative Litigation no. 554/2004.
In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
*In the case of a dispute between the beneficiary and the competent authority, the provisions of common law are applicable.
Additional information
More info:
Links
None
Assistance and problem-solving services
None
Last updated:
17 February 2021
Publicat de către:
A paragraph is a self-contained unit of a discourse in writing dealing with
a particular point or idea. Paragraphs are usually an expected part of
formal writing, used to organize longer prose.
Institution responsible with document:
Publicat de către:
A paragraph is a self-contained unit of a discourse in writing dealing with
a particular point or idea. Paragraphs are usually an expected part of
formal writing, used to organize longer prose.
The National Agency for Medicines and Medical Devices of Romania*
*Content marked with an asterisk (*) has been automatically translated and may not fully reflect the original meaning. For objective interpretation, please consult the Romanian version.
The National Agency for Medicines and Medical Devices of Romania*
Str. Aviator Sănătescu 48
Telefon:
+40213171100
Fax:
+40213163497
Email:
secretariat@anm.ro
Table of contents
Competent entities
Serviciul Registratură și Arhivă
Direcția Generală Inspecție Farmaceutică
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